Compliance Management Featured Articles

  1. How AI Is Revolutionizing Quality Management Systems 8/13/2025

    The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.

  2. Biotech's Plastic Problem Meets Its Match 8/8/2025

    Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.

  3. What Happens When You Refuse To Compromise On Sustainability? 8/8/2025

    Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.

  4. Redefining Process Design And The Evolution Of Critical Process Parameters 8/6/2025

    Effectively managing process parameters and quality attributes is vital for successful drug development. Learn how a Quality by Design approach can optimize your processes and ensure product quality.

  5. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  6. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

    This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

  7. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

    In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.

  8. Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance 7/28/2025

    Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.

  9. Ensuring AI Compliance In Life Sciences: 5 Critical Requirements 7/24/2025

    Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.

  10. How To Solve The Big Challenges Of Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock the full potential of life-changing treatments.